Ophthalmic and Topical Dosage Form New Animal Drugs; Cyclosporine

Riepilogo

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health. The supplemental NADA provides for use of cyclosporine ophthalmic ointment on dogs for management of chronic superficial keratitis (CSK) and changing the approved label claim to management of chronic keratoconjunctivitis sicca (KCS).